The following data is part of a premarket notification filed by Allwin Medical Devices, Inc. with the FDA for Ureteral Stent Open Tip/closed Tip/intraoperative Tip, Ureteral Stent Via Ureterorenoscope Open Tip/closed Tip, Pediatric Ureteral Stent Open Tip/closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/closed Tip, Multiloop Ureteral Stent Open T.
| Device ID | K190659 |
| 510k Number | K190659 |
| Device Name: | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent Via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open T |
| Classification | Stent, Ureteral |
| Applicant | Allwin Medical Devices, Inc. 3305 E. Mira Loma Avenue, Suite 176 Anaheim, CA 92806 |
| Contact | Digish Mehta |
| Correspondent | Digish Mehta Allwin Medical Devices, Inc. 3305 E. Mira Loma Avenue, Suite 176 Anaheim, CA 92806 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-14 |
| Decision Date | 2019-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10812261015276 | K190659 | 000 |
| 10812261013753 | K190659 | 000 |
| 10812261013210 | K190659 | 000 |
| 10812261010691 | K190659 | 000 |
| 10812261010660 | K190659 | 000 |
| 10812261010127 | K190659 | 000 |
| 10812261010110 | K190659 | 000 |
| 10812261010004 | K190659 | 000 |